FDA starts showing its plans for oversight of pharmacy compounding

Abstract

This spring and summer, FDA revealed in several guidance documents what the agency thinks pharmacy compounding should look like now that the relevant provisions in federal law are firmly in place and the agency has a budget for oversight. Some of FDA’s ideas, if incorporated into the final versions of the guidances, could be challenging for hospitals and health systems to implement, said Mark Sullivan, executive director of pharmacy operations for Vanderbilt University Hospital and Clinics (VUHC), based in Nashville. Other hospitals and health systems, such as Tufts Medical Center in Boston, may not be immediately concerned about FDA’s ideas. But as hospitals continue to affiliate or form multihospital systems, said Melissa Ortega, director of the medical center’s inpatient pharmacy operations, a plan to centralize compounding activities may need to be reconsidered. Other than removing the unconstitutional prohibition on advertisements about specific compounded drug products, the Drug Quality and Security Act (DQSA) did not change section 503A of the federal Food, Drug, and Cosmetic Act (FDCA).